Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1; Correction
| Citation | 84 FR 53448 |
| Record Number | 2019-21784 |
| Published date | 07 October 2019 |
| Section | Notices |
| Court | Food And Drug Administration |
53448
Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
the committee. Oral presentations from
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oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 21, 2019. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 22, 2019.
Persons attending FDA’s advisory
committee meetings are advised that
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access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
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If you require accommodations due to a
disability, please contact LaToya Bonner
(see
FOR FURTHER INFORMATION CONTACT
)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21834 Filed 10–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3500]
Fit for Use Pilot Program Invitation for
the Clinical Data Interchange
Standards Consortium for Standard for
Exchange of Nonclinical Data
Implementation Guide: Version 3.1;
Correction
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Correction.
SUMMARY
: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Tuesday, August 20, 2019.
The document announced a ‘‘Fit for Use
Pilot Program Invitation for the Clinical
Data Interchange Standards Consortium
for Standard for Exchange of
Nonclinical Data Implementation Guide:
Version 3.1.’’ The document was
published with the incorrect contact
name, phone number, and email address
in the
FOR FURTHER INFORMATION
CONTACT
section. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT
:
Jesse Anderson, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
348–1816, Jesse.Anderson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
: In FR Doc.
2019–17877, appearing on page 43139,
in the Federal Register of Tuesday,
August 20, 2019 (84 FR 43139), the
following correction is made:
On page 43140, in the first column, in
the
FOR FURTHER INFORMATION CONTACT
section of the document, ‘‘Isaac Chang,
Office of Computational Science, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–4027501, PRAStaff@
fda.hhs.gov.’’ is corrected to read ‘‘Jesse
Anderson, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
348–1816, Jesse.Anderson@
fda.hhs.gov.’’
Dated: September 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21784 Filed 10–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0477]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES
: Fax written comments on the
collection of information by November
6, 2019.
ADDRESSES
: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0078. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT
:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10a.m.–12p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION
: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Investigational Device Exemptions
Reports and Records
OMB Control Number 0910–0078—
Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360j(g)) establishes the statutory
authority to collect information
regarding investigational devices and
establishes rules under which new
medical devices may be tested using
human subjects in a clinical setting. The
Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105–
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